Two-part package for medical implant

ABSTRACT

The invention provides a two-part package and method of use for a pre-attached medical implant and delivery tool system. The package includes a wet compartment and a dry compartment and allows a pre-attached implant and delivery tool system to be at least partially stored immersed in a fluid in the wet compartment and at least partially stored in the dry compartment. In one embodiment the implant comprises a replacement heart valve, and the heart valve is stored inside the wet compartment while the heart valve delivery tool remains dry in the dry compartment.

CROSS-REFERENCE

This application is a continuation of U.S. application Ser. No.13/367,733, filed Feb. 7, 2012, which is a continuation of U.S.application Ser. No. 12/777,161, filed May 10, 2010, now U.S. Pat. No.8,136,659, which is a divisional of U.S. application Ser. No.11/275,913, filed Feb. 2, 2006, now U.S. Pat. No. 7,712,606; whichapplication claims the benefit of U.S. Provisional Application No.60/716,883, filed Sep. 13, 2005. These applications are incorporatedherein by reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention relates to packaging for medical implant anddelivery tools, and specifically to packaging for pre-attached heartvalve and delivery tool systems where the heart valve is stored in afluid and at least part of the delivery tool is stored dry.

Percutaneously delivered tissue based replacement heart valves aretypically packaged in a container filled with a storage solution. Thestorage solution is designed to maintain the biological integrity of theimplant (e.g., implant functionality, sterility, and functionalintegrity) while stored and awaiting use. When needed for implanting ina patient, the container is opened and the valve is removed using avariety of techniques aimed at preventing damage to the valve. Thestorage solution in which the valve was stored is then rinsed from thevalve to prepare it for use. Next, the valve is attached to a devicethat will facilitate delivery of the valve to the appropriate locationin the patient's body. Additional implants may also benefit from beingstored in a solution where a coating or treatment on the implantrequires wet storage to maintain functionality.

SUMMARY OF THE INVENTION

It may be desirable to attach a medical implant to a delivery tool, thusforming a medical implant delivery system, at manufacture, prior to itsstorage and final use. Benefits provided by such pre-attached implantand delivery systems are in part described as follows. The risk ofdamage to the implant and delivery system resulting from the attachmentprocedure will be minimized since the procedure will be performed byexperienced manufacturing technicians specifically trained for the task.The tools and environment will be set up specifically for the task. Itwill be possible to validate the performance of the implant system priorto final packaging. The preparation time required by the physician willbe minimized thereby reducing the cost of the procedure. Thus, apre-attached delivery system would make a medical implant surgery morecost effective, safer, and simpler.

As stated above, many heart valves are currently stored in a storagesolution prior to use. Since a pre-attached implant and delivery toolprovide benefits that an unattached implant and delivery tool do not, itbecomes desirable to be able to store a pre-attached heart valve anddelivery tool system for an extended period of time prior to the implantprocedure. But while it is beneficial to store the implant in a storagesolution, it is not always desirable to store the delivery tool in sucha solution. To do so would require the wet storage container and volumeof storage solution to be larger than required if only the implant isstored in solution. Furthermore, the delivery tool would have totolerate exposure to the solution during storage, which placesadditional design constraints on materials for fabrication of thedelivery tool. In addition, the added step of removing and rinsing thesolution from the delivery tool prior to use would require additionaltime and complicates the use of the device. Thus, it becomes necessaryto be able to store part of the pre-attached delivery system in a liquidmedium, while keeping another part dry. Specifically, it is desirable tokeep the implant stored in fluid while the delivery tool remains dry.

When the valve is ready for implanting in a patient, it will often beinserted into the body in a collapsed configuration thereby minimizingthe delivery cross section and accommodating anatomical limitationsimposed by the particular paths followed within the body to theimplant's intended location. This is specifically the case when animplant is meant to at least partially expand once inside the body toproduce its intended effect. When an implant's configuration is capableof being altered between such expanded and collapsed states, it is oftendesirable to store the implant in a relaxed and expanded condition.Thus, when an implant delivery system as described above is stored foran extended period of time prior to use, it is desirable to maintain theimplant in a relaxed and at least a partially expanded configurationduring storage. Maintaining an expanded configuration will preserve thebiological functionality of the implant, thus making an implant surgerymore effective.

The present invention provides packages and methods of packaging for apre-attached medical implant and delivery tool systems. The packageallows the implant and delivery tool to be stored pre-attached to oneanother, such that the implant can be stored in a storage solution andthe delivery tool can remain at least partially dry.

The package of one aspect of the present invention provides for wet anddry compartments such that a pre-attached implant delivery system canpartially be stored in a fluid and partially stored dry. Specifically,the implant portion of the delivery system can be stored at leastpartially in a fluid while the delivery tool can be at least partiallystored in the dry compartment. In some instances of the presentinvention, the implant comprises a heart valve which can be storedcompletely immersed in fluid contained in the wet compartment.

In some instances of the present invention the package comprises aninterface between the wet and dry compartments. The interface may have asealing mechanism to prevent fluid inside the wet compartment fromleaking into the dry compartment. The seal between the wet compartmentand dry compartment may comprise a seal ring compressed against thedelivery tool. A seal may also be formed by a device inside the deliverytool which creates the seal. An exemplary device may be an inflatablemember. Another device may be a compression driven device. In otherinstances of the present invention multiple seals may be used to form asystem of seals which create an interface between the wet and a drycompartment. In one such instance one seal may be formed around anoutside surface of the delivery system and another seal formed withinsome portion of the delivery tool. It is another feature of someembodiments of the invention that an interface between the dry and wetcompartments comprises a strain relief mechanism that reduces the riskof breakage of the delivery tool resulting from its bending duringstorage and use.

Also a feature of some embodiments of the invention is the incorporationwithin the wet compartment of a mechanism to flush fluid from the wetcompartment and or facilitate rinsing the implant with a rinsingsolution within the wet compartment prior to the implant's use.

In another embodiment the implant is substantially centered within thewet compartment by features in the wet compartment.

In yet another embodiment the wet compartment incorporates featureswhich minimize the amount of storage solution required to keep theimplant submerged irrespective of the orientation of the package.

In another embodiment the wet compartment has an upper and a lowerhousing, and may have at least two gaskets between the housings. In someinstances there may be only one gasket.

Another aspect of the invention provides a method of packaging apre-attached medical implant and delivery tool by providing an implantpre-attached to a delivery tool, wet and dry package compartments, andloading the implant at least partially into the wet compartment suchthat the delivery tool is at least partially stored in the drycompartment. In one embodiment the implant is loaded into the wetcompartment in a first configuration and reconfigured to a secondconfiguration. The implant may be covered by a sheath in the firstconfiguration and not covered by a sheath in the second configuration.

Yet another aspect of the invention provides a method of unpacking apre-attached medical implant and delivery tool system from a package. Inone embodiment the method includes providing an implant pre-attached toa delivery tool such that at least part of the implant is storedimmersed in fluid, and the delivery tool is at least partially stored ina dry compartment. Fluid in the wet compartment is then flushed from thewet compartment, possibly with a rinsing solution and or with air. Theconfiguration of the implant is altered from one configuration to asecond configuration, and the implant is removed from the wetcompartment.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 show alternative embodiments of a two-part package of thepresent invention.

FIG. 3 illustrates an implant stored in a wet compartment immersed influid.

FIGS. 4A-B provide exemplary cross-sectional views of a wet compartment.

FIGS. 5A-G show seal systems that prevent fluid from escaping the wetcompartment into the dry compartment.

FIG. 6 shows a bottle and cap embodiment of the wet compartment and sealmechanism.

FIG. 7 illustrates an embodiment of the seal in which the seal is formedby compression fitting.

FIG. 8 shows an embodiment of the wet compartment and seal mechanism.

FIGS. 9 and 10 provide a seal assembly used in the present invention.

FIG. 11 shows a cross-sectional view of a seal assembly used in theinvention.

FIG. 12 shows an unloaded state of a seal.

FIG. 13 illustrates a loaded state of a seal which prevents fluid fromescaping the wet compartment.

FIG. 14 shows an embodiment of the seal mechanism.

FIG. 15A-B illustrates a delivery tool seal.

FIGS. 16A-B illustrates a delivery tool seal.

FIG. 17 show a delivery tool wedge compression seal.

FIGS. 18A-G show an alternative seal located within the handle of thedelivery tool.

FIG. 19 shows a strain relief mechanism of the seal cap to protect thedelivery tool during bending.

FIG. 20 shows an embodiment of a bottle style wet container for thepackage and a portion of the delivery system.

FIG. 21 shows an alternate cross section of a wet container for thepackage.

FIG. 22 illustrates a clam shell embodiment of a wet container for thepackage assembled.

FIG. 23 shows a clam shell embodiment of a wet container for the packagein an exploded view using two gaskets to seal the container.

FIG. 24 depicts a clam shell embodiment of a wet container for thepackage in an exploded view using a single gasket to seal the container.

FIG. 25 shows a detail of a clam shell embodiment of a wet container forthe package in an exploded view using a single gasket to seal thecontainer.

FIGS. 26A-D show a depiction of a method for introducing and removing animplant from a wet container.

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

The invention is drawn to a two-part packaging system for a medicalimplant delivery system. In some embodiments, the invention allows animplant to be pre-attached to a delivery tool and stored in an expandedand relaxed state in a storage solution while at least a portion of thedelivery tool remains dry. The packaging system includes a wetcompartment that is suitable for holding fluid and a dry compartmentthat remains dry, with a pass through between the two compartments toallow an implant delivery system to be stored partially in the wetcompartment and partially in the dry compartment. This arrangementallows for the implant to be attached to the delivery tool prior toplacement into the packaging system, creating a pre-attached implantdelivery system. In one embodiment the implant portion of the deliverysystem is stored in the wet compartment and the delivery system isstored in the dry compartment. This arrangement allows the implantportion of the implant delivery system to be stored in fluid whilepreventing a portion of the delivery portion of the implant deliverysystem from being exposed to the fluid. In one embodiment of theinvention the delivery system is comprised of a replacement heart valveconnected to a delivery tool for delivering the heart valve to a desiredlocated within a patient. The heart valve connected to the delivery toolmay be stored inside the wet compartment while the delivery tool isstored inside the dry compartment. When the implant is ready for use thewet compartment may be drained of the fluid and or rinsed with a rinsingfluid, the implant can be removed from the packaging system and furtherprepared for use. This system thus simplifies, reduces risks of, andspeeds the implant surgery because the delivery system is pre-attachedprior to use and thus the user does not have to attach the implant tothe delivery tool during the surgery. In still other embodiments theimplant is stored partially in the wet compartment and partially in thedry compartment, and the delivery system is stored entirely in the drycompartment.

Possible implants envisioned for storage in the packaging system of theinvention include those described in applications: Ser. No. 10/746,280entitled “REPOSITIONABLE HEART VALVE AND METHOD,” filed on Dec. 23,2003; Ser. No. 10/893,131 entitled “METHODS AND APPARATUS FORENDOVASCULARLY REPLACING A PATIENT′S HEART VALVE” filed on Jul. 15,2004; Ser. No. 10/893,151 entitled “METHODS AND APPARATUS FORENDOVASCULARLY REPLACING A PATIENT′S HEART VALVE” filed on Jul. 15,2004; Ser. No. 10/746,120 entitled “EXTERNALLY EXPANDABLE HEART VALVEANCHOR AND METHOD” filed on Dec. 23, 2003; Ser. No. 10/746,285 entitled“RETRIEVABLE HEART VALVE ANCHOR AND METHOD” filed Dec. 23, 2003; Ser.No. 10/982,692 entitled “METHODS AND APPARATUS FOR ENDOVASCULARLYREPLACING A HEART VALVE” filed on Nov. 5, 2004; Ser. No. 10/746,872entitled “LOCKING HEART VALVE ANCHOR” filed on Dec. 23, 2003; and Ser.No. 10/870,340 entitled “EVERTING HEART VALVE” filed on Jun. 16, 2004.

One embodiment of package 1 is shown in FIG. 1. Exemplary package 1comprises a wet compartment 3, at least partially contained withincontainer 4 and a dry compartment 5. The parts of an implant and itsdelivery system stored in wet and dry compartments may differ accordingto the materials, design, etc. of the implant and delivery system. Inthe embodiment shown in FIG. 1, an implant 7 is connected to a deliverytool 9 such that implant 7 is stored inside wet compartment 3, whiledelivery tool 9 and wet compartment 3 are stored inside the drycompartment 5. An interface 11 between the wet compartment 3 and the drycompartment 5 allows implant 7 to be connected to delivery tool 9 whilestoring implant 7 in a wet compartment 3 and keeping at least a portionof delivery tool 9 dry. Alternatively, a portion of the wet compartmentmay extend into the delivery tool and be additionally sealed withinhandle 6. In some embodiments the implant 7 may be partially storedinside the wet compartment 3. In other embodiments the delivery tool 9may be partially stored in the dry compartment 5. In further embodimentsimplant 7 may be partially stored in the wet compartment and deliverytool 9 may be partially stored in the dry compartment. Package 1 may becylindrical in shape, or may have a rectangular cross-section. Thepackage may also be any other size, shape, or configuration that issuitable to store a pre-attached implant and delivery tool under theconditions of this invention. FIG. 2 shows another embodiment of package1 where implant 7 is stored inside wet compartment 3 while delivery tool9, which is connected to implant 7, and wet compartment 3 are storedinside dry compartment 5. The configurations of the delivery systemshown in FIGS. 1 and 2 illustrate how at least key portions of theimplant are maintained during storage in solution while at least part ofthe delivery tool remains dry and unexposed to the storage solution.

FIG. 3 shows one embodiment of wet container 4 comprising at least aportion of wet compartment 3. Delivery tool 9 comprising guide wire tube21, which is connected to nose cone 23 is connected to implant 7.Implant 7 is stored inside wet compartment 3 which is filled with fluid17 to keep the implant 7 wet during storage. Seal 13 prevents fluid 17from escaping wet compartment 3. Exemplary wet container 4 has a part 19with a luer connector used to flush and remove fluid 17 from wetcompartment 3 prior to use of the implant. In some embodiments the wetcompartment may comprise only one flushing part. In other embodimentsthe wet compartment may contain at least two or more flushing parts.FIG. 3 illustrates implant 7 in its expanded and relaxed configuration.This configuration is desirable during storage to maintain thebiological functionality of the implant.

In some embodiments fluid 17 comprises a storage solution to preservethe functionality of implant 7 during storage in the package system.Fluid 17 may comprise a saline solution or any other storage solution.In some embodiments fluid 17 may comprise a sterilant and or fixativesolution such as gluteraldehyde or formalin. In still other embodimentsthe fluid 17 may comprise a bacteria static solution to prevent bacteriafrom growing in the fluid. The fluid may also be a buffered solution. Insome embodiments the solution may be comprised of a physiological saltor an alcohol. In further embodiments the fluid 17 may be anycombination or mixture of the solutions described above, or any othersolutions to achieve the intent of this invention.

In one embodiment the implant 7 comprises a replacement heart valve. Insome embodiments the replacement heart valve may be comprised of tissuefrom a human, porcine, or other suitable animal. In some embodiments theheart valve may comprise a mechanical heart valve, bioprosthetic heartvalve, polymer heart valve, or any other type of artificial heart valvetreated in such a fashion as to require storage in a storage solution.In some embodiments the implant may comprise any combination of theabove heart valves suitable for the present invention. In someembodiments implant 7 may also comprise implantable devices other thanheart valves, for example, but not limited to, vascular grafts,angioplasty rings, and stents, musculoskeletal grafts, grafts specificto other body ducts including the digestive system or lymphatic system.

FIG. 4A shows an exemplary cross-section of the distal end of wetcontainer 4 from FIG. 3, while FIG. 4B show a more proximally locatedcross-section of wet container 4 from FIG. 3. In some embodiments thecross-section of the wet compartment is triangular in shape. Such ashape minimizes the amount of fluid required to assure the implant isimmersed in fluid over the range of possible orientations the containermay be subjected to while in storage. A further benefit of thetriangular shape or other non cylindrical shapes of the cross-section isto present a variable cross section of the fluid which acts as a maskfor radiation. The wet container can then be designed to minimize theexposure to sterilizing radiation of portions of its contents. In otherembodiments of the invention the cross section of the wet container mayhave a circular shape, a rectangular shape, or any other shape suitablefor this invention. In further embodiments of the invention the wetcontainer may have a combination of any of the above cross sectionalshapes distributed across the wet container. The desired shape of thecross section of the wet compartment may depend on the type and size ofthe delivery system being stored in the package, the type and size ofthe implant stored in the wet compartment, both the type and size of thedelivery system and the implant, the type of sterilization procedure, orany other factor. It is desirable that the size and shape of wetcontainer 4 allows the implant 7 to be stored in an expanded and relaxedstate during storage, allowing for greater biological functionality whenthe implant is inside a patient.

In some embodiments of the present invention a seal is formed betweenthe dry compartment and wet compartment to prevent fluid inside the wetcompartment from escaping into the dry compartment. A seal allows theimplant to be stored in fluid to maintain its biological integrity,while keeping the delivery tool dry. An exemplary seal may be formedwhen a seal cap is screwed or attached onto a receiving member of thedelivery system, forcing a compressing member against the delivery tool,creating the seal. FIGS. 5A-G illustrate similar embodiments of anexemplary seal that prevents fluid from entering the dry compartment ofthe packaging system. Exemplary seal 13 is created when seal ring 29 iscompressed against the outer periphery of multi-lumen catheter 28 bycompression fitting to fill space 30. Seal ring 29 is compressed whenseal cap 15 is screwed onto wet container 4 such that male threads 31 ofseal cap 15 engage female threads 33 of wet container 4. FIGS. 5A-E showexemplary configurations of seal ring 29 that may be used in the currentinvention to create a seal between the wet compartment and drycompartment. Any other suitable shape of seal ring may be used inaccordance with this invention. In another embodiment shown in FIGS. 5Fand 5G, seal ring 29 is compressed against the multi-lumen catheter 28by folder member 35.

FIG. 6 illustrates one embodiment of the invention using a bottle andcap assembly. Seal cap 15 is screwed onto bottle-shaped wet container 4as described above to create the seal. The shape of wet container 4allows the implant 7 to be stored in an expanded and relaxed state, butany other size, shape, or configuration of wet container 4 may be usedto carry out the intent of the invention. FIG. 7 is a detailed sectionalview of the seal mechanism depicted in FIG. 6. Exemplary seal cap 15comprises seal cap arm 49, which causes elastomer compression fittingarea 55 to compress against delivery tool 9 when seal cap 15 is screwedonto wet container 4, such that male threads 31 of seal cap 15 engagefemale threads 33 of wet container 4. When seal cap 15 is screwed ontowet container 4, seal cap arm 51 pushes elastomer compression fitting 53against V-rib 67 of wet container 4, sealing the wet container 4 toelastomer compression fitting 53.

FIGS. 8-13 illustrate another embodiment of the interface 11 where sealassembly 61 is comprised of elastomer diaphragm 63 and plastic supportspring 65. In FIG. 12, the seal assembly is shown in an unloaded state.In FIG. 13 seal cap 15 is screwed onto wet container 4, causing theinner rim 64 of seal cap 15 to push and straighten spring ridges 66 andelastomer diaphragm 63, compressing elastomer diaphragm area 68 againstdelivery tool 9, creating a seal. V-rib 67 of wet container 4 creates aseal between the wet container 4 and elastomer diaphragm 63 when sealcap 15 is completely screwed onto wet container 4. In another embodimentof the seal shown in FIG. 14, an exemplary seal against the deliverytool is maintained by the elasticity of the elastomer diaphragm seal 71.The seal cap 15 is screwed onto wet container 4 as described above,causing elastomer diaphragm seal 71 to be compressed against container4. The examples of the seals above allow the implant to be at leastpartially stored in solution in the wet compartment of the deliverysystem while preventing fluid from escaping, thus keeping the deliverytool dry. The use of a seal further allows the implant to bepre-attached to the delivery tool such that the delivery tool can bekept at least partially dry during storage.

In other embodiments of the invention an additional seal between the wetcompartment and the dry compartment may be required and is created by adevice or mechanism inside the delivery tool. Referring to FIG. 15A, anexemplary seal is created by inflatably expanding member 75, collapsingmulti lumens 77 of implant 7 against ring 76 the outer periphery of thedistal end of the delivery tool. Alternatively as depicted in FIG. 15B,the exemplary seal created by inflatably expanding member 75, collapsingmulti lumens 77 of implant 7, may seal against wet container 4. Theinflatably expanding member 75 is inflated by central lumen 81 which islocated within delivery tool 9. In some embodiments, the central lumen81 inflates the inflatably expanding member 75 with air, liquid, or anyother substance or gas that is suitable for the present invention. Inanother embodiment of the seal, FIGS. 16A and 16B show inflatablyexpanding member 75 pushing multi-lumens 77 of implant 7 into slots 82within wet container 4 to create a smooth sealing surface. Theseexemplary seals prevent fluid inside the wet compartment from escapinginto the dry part of the delivery system, allowing the implant to bestored in a storage solution while keeping at least a portion of thedelivery tool dry.

In another embodiment shown in FIG. 17, the delivery tool 9 comprises adriven compression component 83 and elastomer compressible component 87,wherein, by forcing the compression component into the compressiblecomponent, the compression caused be component 83 against the compressedcomponent 87 collapses multi-lumens 77 against the wet container 4,creating a seal between the wet compartment 3 and the dry compartment ofthe implant delivery system. In some embodiments of the invention,compression component 83 comprises a conical shape such that expandingmember 83 wedges between elastomer 87, collapsing multi-lumens 77against the wet container 4 to create the seal.

In yet another embodiment the additional seal may be incorporated in thehandle as depicted in FIGS. 18A-G. Such a seal may in additionincorporate an homeostatic seal which provides additional functionalityto the implant deployment system. FIG. 18A shows an embodiment in whichactuation elements 1810 extend from a chamber within the deployment toolhandle 1804 into lumens 1812 extending through a tapered adapter portion1806 into a catheter 1802 of the deployment tool. A balloon 1808 orother inflatable device may be inflated during storage to maintain anystorage solution within catheter 1802 and lumens 1806 (and possiblysurrounding any implant connected to the deployment tool). Balloon 1804may be deflated prior to use to permit the storage fluid to be drainedand or rinsed from the device through port 1814. During use, handle endcap 1816 provides a homeostatic seal permitting actuation elements 1810but substantially preventing blood to escape from handle 1804. Such ahomeostatic seal may be configured from a thin sheet of silicone throughwhich the actuation elements pass. Wherein the interface between thesilicone sheet and actuation elements comprises an interference fit.

FIG. 18B shows an embodiment similar to that of FIG. 18A in whichballoon 1808 has a central lumen 1818 permitting other devices (such asactuation elements 1820) to pass through toward the distal end of thedeployment tool.

FIG. 18C shows an embodiment in which the actuation elements 1810 passthrough holes 1822 formed in an elastomeric plug 1824. To seal thedeployment tool system during storage, slidable bars 1826 and 1828 of aseal actuator are moved toward each other along a guide 1830 to compressplug 1824 and seal holes 1822 around actuation elements 1810. Thisaction maintains storage fluid within catheter 1802 and around anyimplant connected to the deployment tool.

FIG. 18D shows an embodiment in which the actuation elements 1810 passthrough flexible tubes 1832 within handle 1804. Pressurized fluid may beprovided to the interior of handle 1804 through a valved port 1814 tocollapse tubes 1832 around actuation elements 1810, thereby retainingany storage fluid within catheter 1802 (and around any attached implant)during storage. Storage fluid may be drained and or rinsed from thesystem by port 1814 before use of the deployment tool.

FIG. 18E shows an embodiment in which the actuation elements passthrough holes (not shown) formed in handle portion 1838 and throughholes 1834 formed in a rotating handle endpiece 1836. Rotation ofendpiece 1836 in the direction shown takes holes 1834 out of alignmentwith their corresponding holes in handle portion 1838, thereby sealingin any storage fluid in the interior of tapered handle portion 1806 andcatheter 1802 (and any attached implant). Endpiece 1836 may be rotatedthe other direction to line up the holes to permit actuation elements1810 to be moved during use of the deployment tool.

FIG. 18F shows an embodiment in which the actuation elements 1810 passthrough holes 1842 in an endpiece 1840 made at least in part of wax orlow durometer elastomer or some frangible material. While in storage,holes 1842 seal around actuation elements 1810 to retain storage fluidwithin the deployment tool and any attached implant. Prior to use,storage fluid may be drained and or rinsed from the system through port1814. Movement of actuation elements 1810 through holes 1842 breaks theseal formed by the frangible material, thereby permitting deploymenttool to be used to deploy the implant.

FIG. 18G shows an embodiment in which the actuation elements 1810 passthrough holes 1844 formed in an elastomeric plug 1846 extending from theproximal end of the deployment tool handle. Distal movement of plug 1847(in the direction of the arrows) compresses plug 1846 against thesurface of tapered handle portion 1806 and outer cylinder 1849. Thisaction compresses holes 1844 against actuation elements 1810, therebysealing the deployment tool and retaining any storage fluid within it.

It is desirable that the delivery system can be stored, transported, andused without undergoing damage to the system due to bending frommovement or manipulations from any number of sources. In a furtherembodiment of interface 11 as shown in FIG. 19, exemplary seal cap 15comprises a strain relief feature embodied in component 89 to protectdelivery tool 9 from damage due to small radius bends in the deliverytool 9 during storage and use. In some embodiments the strain reliefcomponent may be smooth, and in some embodiments the strain reliefmechanism may have internal and external ribs. In some embodiments thestrain relief component may be removably attached to the seal cap.

An alternate embodiment of wet container 4 as shown in FIGS. 20 and 21incorporates infolded wings 91 within wet container 4 to provide thesame functionality as that described for FIGS. 4A and 4B. Additionalsupport of the infolded wings 91 may be provided by a backboard 92 onthe device packaging, as shown in FIG. 21.

In a further embodiment as shown in FIGS. 22 and 23, exemplary wetcontainer 4 comprises an upper housing 95 and lower housing 97, and anupper gasket 101 and lower gasket 103 which create the seal between thewet compartment and the dry compartment of the packaging system. Thisembodiment is desirable because it allows the seal to be created simplyby the interface between the delivery tool, gaskets, and housings. Thegaskets prevent the fluid from escaping the wet compartment, thuskeeping the delivery tool dry. In some embodiments the upper and lowergaskets 101 and 103 could be molded to the upper and lower housings 95and 97, respectively. In other embodiments the gaskets could be bondedto the housings with adhesive material or maintained by interferencefits. In other embodiments the housings and gaskets could remainseparate, loose parts. In further embodiments the seal could be createdfrom a single gasket 102 within housings as illustrated in FIGS. 24 and25. Such an embodiment might require the gasket to be broken for removalfrom the delivery tool prior to use of the implant delivery system.

The present invention also draws on methods of packaging an implant thatis pre-attached to a delivery tool used to deliver the implant to aspecific location within a patient. The implant is loaded into a wetcompartment of the package such that the delivery tool remains in thedry compartment of the package. In some embodiments the implant ispartially stored in the wet compartments. In other embodiments thedelivery tool is partially stored in the dry compartment. In furtherembodiments the implant is partially stored in the wet compartment andthe delivery tool is partially stored in the dry compartment. The methodof storing an implant pre-attached to a delivery tool allows thedelivery system to be used immediately after it is removed from thepackaging, such that a user subjected to the concerns associated withattaching an implant to a delivery tool in the procedure setting. Thisprovides for a quicker, safer, and more efficient procedure.

One embodiment of the packaging method is shown in FIGS. 26A-C. Sheathedimplant 125 is first loaded through seal cap 15 and further into wetcompartment 3. FIG. 26B illustrates the step of unsheathing theexpanding implant 127 while sheath 123 is urged towards the proximal endof wet compartment 3. Once the sheath 123 has been completely removedfrom expanding implant 129 as shown in FIG. 26C, seal 13 can be formedusing any of the examples discussed above to prevent fluid [not shown]from escaping wet compartment 3. After the seal 13 is formed, theexpanded implant can be stored inside wet compartment 3, immersed influid [not shown], for an extended period of time as needed. The methodof storing expanded implant 129 allows the implant to retain a naturaland relaxed configuration during storage which allows for a morebiologically functional implant to be inserted into a patient. The dualcompartment design of the invention allows the implant to be retained inthis relaxed state during storage while being preserved in a solutionwhich is maintained inside the wet compartment, such that the deliverytool remains at least partially dry in the dry compartment.

When the implant 129 is needed for use, the flushing luer part 19 asshown in FIG. 3 can be used to flush and or rinse the fluid 17 out ofwet compartment 3. Referring now to FIGS. 26C-D, seal 13 can then bereleased in a reverse manner to any of the methods of creating the sealdiscussed above, or any other seal creating mechanism which may be knownin the art. Once seal 13 is released, sheath 123 can then be distallyslid to resheath the implant 131 until the implant is again in a fullysheathed state 125. The implant can then be removed from the wetcompartment 3 and further prepared for use. The pre-attached storageallows for immediate use and eliminates the step of a user attaching animplant to a delivery tool during surgery.

It will be necessary to sterilize part of all of the implant deliverysystem to prevent infection when the delivery system is inserted into apatient. In some embodiments the fluid in the wet compartment in whichthe implant is immersed during storage may be sterilized to maintain asterile environment for the implant during storage. In other embodimentsit may be desirable to sterilize the delivery tool of the implantsystem, either alone or in conjunction with the fluid. Sterilization inthe present invention may be by chemical, heat, irradiation, gas, or anyother known means. The dual compartment design of the invention allowsthe implant to be stored in solution, yet provides the added benefitthat the fluid may be used as a mask to radiation sterilization suchthat if the entire delivery system is sterilized, the implant willreceive a smaller dose of sterilization than the delivery tool due tothe masking effect of the fluid. This smaller dose received by theimplant will reduce the risk of damage and loss of functionality of theimplant components susceptible to radiation damage such as certainpolymers and tissue components.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A medical implant and delivery tool package comprising: a wetcompartment containing a fluid; a dry compartment; a replacement heartvalve implant at least partially stored inside the wet compartment; anda delivery tool at least partially stored inside the dry compartmentwherein the replacement heart valve implant is configured to transitionbetween a compressed configuration within the delivery tool and anexpanded configuration within the wet compartment.
 2. The medicalimplant and delivery tool package of claim 1, wherein the wetcompartment is configured to maintain the replacement heart valveimplant immersed in fluid regardless of orientation of the wetcompartment.
 3. The medical implant and delivery tool package of claim1, wherein an interface between the wet compartment and the drycompartment stores the replacement heart valve implant in the wetcompartment and keeps at least a portion of the delivery tool dry. 4.The medical implant and delivery tool package of claim 1, wherein thewet compartment is stored inside the dry compartment.
 5. The medicalimplant and delivery tool package of claim 1, wherein a shape of the wetcompartment is non-cylindrical.
 6. The medical implant and delivery toolpackage of claim 5, wherein a cross-section of the wet compartment istriangular in shape.
 7. The medical implant and delivery tool package ofclaim 1, further comprising a seal cap threadably engaged with the wetcompartment, thereby preventing the fluid from entering the drycompartment.
 8. The medical implant and delivery tool package of claim7, wherein the seal cap engages a seal member against an exteriorsurface of the delivery tool when the seal cap is threadably engagedwith the wet compartment.
 9. The medical implant and delivery toolpackage of claim 1, wherein the delivery tool is attached to thereplacement heart valve implant.
 10. The medical implant and deliverytool package of claim 9, wherein the delivery tool includes a sealdisposed within the delivery tool configured to prevent the fluid insidethe wet compartment from escaping into a dry portion of the deliverytool.
 11. A method of storing a medical implant, comprising: attaching amedical implant to a delivery tool; translating the medical implant intoa compressed configuration within the delivery tool; inserting a distalend of the delivery tool into a wet compartment; unsheathing the medicalimplant within the wet compartment; and placing the delivery tool andthe wet compartment into a dry compartment.
 12. The method of storing amedical implant of claim 11, wherein the wet compartment is filled withfluid.
 13. The method of storing a medical implant of claim 11, whereininserting the delivery tool into the wet compartment includes insertingthe delivery tool through a seal cap.
 14. The method of storing amedical implant of claim 11, wherein the medical implant is storedwithin the wet compartment in an expanded configuration.
 15. The methodof storing a medical implant of claim 12, further comprising forming aseal to prevent the fluid from escaping the wet compartment.
 16. Themethod of storing a medical implant of claim 15, wherein the seal isformed after the medical implant is completely removed from the deliverytool.
 17. The method of storing a medical implant of claim 11, furthercomprising irradiating the dry compartment to sterilize the deliverytool.
 18. The method of storing a medical implant of claim 17, whereinthe wet compartment masks the medical implant from radiation.
 19. Themethod of storing a medical implant of claim 11, wherein the medicalimplant is a replacement heart valve.